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  • Writer's pictureShelly Albaum

Happy 1st Birthday FDA Interim Response!

A year ago today the FDA issued the following preliminary response to ChromaDex's FDA petition:

"We have not reached a decision on your petition with in the first 180 days...However, be advised that your petition is currently under active evaluation by our staff."

I'd say that was a lie, because they also did not reach a decision in the second 180 days, or the third 180 days, and today is Day 546 with no response from the FDA.

We can partly blame this on the general defunding of the government by Republicans, as well as the intentional demolition of the federal agencies by the Trump administration (see The Fifth Risk, by Michael Lewis, for details), which leaves federal civil servants helplessly confronted by an infinity of work without the resources, technology, systems, or training to handle it.

But part of the problem, too, lies in the general corruption of the supplement regulatory scheme under DSHEA, which is celebrating its own 25th birthday this year.

The federal district court in New York, in dismissing Elysium's legal claims based on the citizen petition, reduced the legal urgency for the FDA to validate ChromaDex's substantive concerns about toluene, which could have -- if the FDA had acted -- saved the SDNY some time in concluding that ChromaDex's citizen petition was not objectively baseless.

But a response from the FDA would still be important to validate ChromaDex's procedural concerns with Elysium's alleged attempt to free-ride on ChromaDex's NDIN. Here is how ChromaDex put it in its supplemental comment, authored by King & Spalding's Sheldon Bradshaw, who was formerly Chief Counsel to the FDA and knows of what he speaks:

ChromaDex Requests That FDA Finalize Its NDIN Guidance and Clarify Its Enforcement Policy With Respect to Dietary Supplement Manufacturers That Include a New Dietary Ingredient in Their Products Without Complying With Section 413(a) of the FD&C Act [21 U.S.C. § 350b(a)].

ChromaDex is concerned that FDA is not prioritizing enforcement of the NDIN requirement established in Section 413(a) of the FD&C Act [21 U.S.C. § 350b(a)]. As noted above, ChromaDex' s Citizen Petition highlighted the fact that Elysium is distributing its NR product, Basis, without having submitted the required NDIN. In its comment, Elysium did not try to justify its failure to file the required notification (which it cannot), nor did it promise to rectify the problem by submitting the required notification in the future. Elysium did not bother to address this issue in its comment at all.

Elysium's willingness to ignore this issue (along with its exposure to potential civil and criminal sanctions) should be a wake-up call for FDA. If FDA does not prioritize enforcement in this area, then the NDIN requirement will become a dead letter in the law. The failure to enforce the requirement only serves to punish legitimate dietary supplement manufacturers who undertake the burden, time, and expense of preparing the required notification, including responding to any issues raised by FDA. As a result, if FDA chooses not to enforce the notification requirement, then compliance will erode even further...

ChromaDex requests that FDA issue a similar Compliance Policy Guide, or other public announcement, emphasizing that the agency will prioritize enforcement of the NDIN requirement in cases where a manufacturer has taken the necessary steps to comply with the requirement, but other manufacturers either start or continue to distribute products containing the same New Dietary Ingredient without complying with the law. After all, FDA should want to encourage voluntary compliance with the NDIN requirement because such voluntary compliance benefits the public health by increasing the assurance that dietary supplements contain only safe ingredients.

Elysium may not claim ChromaDex's NDIN for its product. FDA has already stated in a Draft Guidance on NDINs that each manufacturer of a New Dietary Ingredient must comply with the notification requirement. FDA explained that the FD&C Act is not designed to allow New Dietary Ingredients to be distributed en mass by various manufacturers under the cover of a single notification filed by one manufacturer. In fact, this situation demonstrates precisely why a separate notification is needed. ChromaDex's NDIN for NR highlighted substantial manufacturing controls that preclude the use of toxic solvents like toluene. Elysium's NR product, however, is contaminated with toluene. The fact that one manufacturer has submitted a NDIN does not demonstrate that the same or similar New Dietary Ingredient manufactured by a different company "will reasonably be expected to be safe." (footnotes omitted, emphasis added)

So regardless of whether there is in fact toluene in Basis, or whether it was removed, or whether the ICH guidelines for pharmaceuticals can be relied on by manufacturers of health supplements, there remains an important question about whether there are any consequences for failing to comply with DSHEA's NDIN requirement, or for failing to timely comply.

The FDA may actually take this issue seriously. Last week, FDA Commissioner Scott Gottlieb released a statement on the agency's new efforts to strengthen regulation of dietary supplements. Commissioner Gottlieb says,

"One of my top goals is...holding accountable those actors who are unable or unwilling to comply with the requirements of the law....The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications. An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources. We’re continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients. In conjunction with this effort, we’re planning to update our compliance policy regarding NDIs." (emphasis added)

Well, we'll see.

The agency's inability to even respond to a citizen petition that raises the PRECISE issue that the agency professes to be concerned about is inauspicious.

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